Antiseptic spermicidal composition and means for its application

Abstract

This invention provides a spermicidally and virucidally effective, vaginally applicable formulation, having the following approximate composition of essential ingredients: at least one benzalkonium chloride, in an amount from 0.05 to 0-0.2%; at least one spermicide selected from the group consisting of nonoxynols in an amount of from 0.05-12%, octoxynol-9 in an amount of from 0.05-4%, and triclosan in an amount from 0.05-2%; a biologically acceptable emollient, in an amount from 1-5%; hydroxypropyimethyl cellulose, in an amount from 0.1-3%; sodium carbomer, in an amount from 0.1-1%; de-ionized water, making up the balance. The composition has the attributes of (a) a semi-solid, essentially clear gel consistency and appearance, and (b) the ability to maintain a presence in the human vagina in the presence of mucous secretions therein, in virucidally effective amounts, for at least 24 hours after application thereto.

In the claims:  
     
         1 . A spermicidally and virucidally effective vaginally applicable formulation, comprising: 
 (i) at least one benzalkonium chloride, in an amount from 0.05 to 0.2% by weight;    (ii) octoxytnol-9 in an amount from about 0.05-2% by weight;    (iii) a biologically acceptable emollient, to provide appropriate consistency;    (iv) hydroxypropylmethyl cellulose, in an amount from 0.1-3% by weight;    (v) sodium carbomer, in an amount from 0.1-1% by weight; and    (vi) de-ionized water, making up the balance,    wherein the formulation possesses the attributes of (a) a semi-solid, essentially clear gel consistency and appearance, and (b) the ability to maintain a presence in the human vagina along with mucous secretions therein, in virucidally effective amounts, for at least 24 hours after application thereto.    
     
     
         2 . The formulation of  claim 1  wherein the emollient is glycerine.  
     
     
         3 . The formulation of  claim 2  wherein the glycerine is present an amount from about 1-10% by weight.  
     
     
         4 . A kit for vaginal self-use by a female patient in protection against contacting viral infection and against conception as a result of normal heterosexual intercourse, said kit comprising a vaginal applicator comprising a vaginally insertable tubular member having a length of about five inches, and having a aperturable distal end adapted to be positioned adjacent to the patient's cervix when the applicator is fully inserted into the patient's vagina, and at least one unit dose of from about 5-10 mls of a spermicidally and virucidally effective formulation comprising: 
 (i) at least one benzalkonium chloride, in an amount from about 0.05 to 0.2% by weight;    (ii) octoxynol-9 in an amount from about 0.05-0.2% by weight;    (iii) a biologically acceptable emollient, to provide appropriate consistency;    (iv) hydroxypropylmethyl cellulose, in an amount from about 0.1-3% by weight;    (v) sodium carbomer, in an amount from about 0.1-1% by weight; and    (vi) de-ionized water, making up the balance.    
     
     
         5 . The kit of  claim 4  wherein the applicator has a squeezable reservoir containing said formulation, in communication with said tubular member.  
     
     
         6 . The formulation of  claim 3  wherein the benzalkonium chloride is present therein in an amount of from about 0.05-0.12% by weight.  
     
     
         7 . The formulation of  claim 6  wherein the benzalkonium chloride is selected from the group consisting of alkyl dimethylbenzyl ammonium chloride with alkyl groups of C 12 -C 18  in length, alkyl dimethlethylbenzyl ammonium chloride with alkyl groups of C 12 -C 18  in length, mixtures thereof and myristylbenz-alkonium chloride.  
     
     
         8 . The kit of  claim 4  wherein the emollient in the composition is glycerine, in an amount of from 1-10% by weight.  
     
     
         9 . The kit of  claim 8  wherein the benzalkonium chloride of the formulation is present therein in an amount of from about 0.05-0.12% by weight.  
     
     
         10 . The kit of  claim 9  wherein the benzalkonium chloride of the formulation is selected from the group consisting of alkyl dimethylbenzyl ammonium chloride with alkyl groups of C 12 -C 18  in length, alkyl dimethylethylbenzyl ammonium chloride with alkyl groups of C 12 -C 18  in length, mixtures thereof and myristylbenzalkonium chloride.  
     
     
         11 . The formulation of  claim 6  wherein the benzalkonium chloride is selected from the group consisting of alkyl dimethylbenzyl ammonium chloride with alkyl groups of C 12 -C 26  in length, alkyl dimethylethylbenzyl ammonium chloride with alkyl groups of C 12 -C 26  in length, mixtures thereof and myristylbenzalkonium chloride.  
     
     
         12 . The kit of  claim 9  wherein the benzalkonium chloride is selected from the group consisting of alkyl dimethylbenzyl ammonium chloride with alkyl groups of C 12 -C 26  in length, alkyl dimethylethylbenzyl ammonium chloride with alkyl groups of C 12 -C 26  in length, mixtures thereof and myristylbenzalkonium chloride.  
     
     
         13 . A spermicidally and virucidally effective, vaginally applicable formulation comprising: 
 (i) at least one benzalkonium chloride, in an amount of about 0.10-0.12% by weight;    (ii) octoxynol-9 in an amount of about 0.2% by weight;    (iii) a biologically acceptable emollient, to provide appropriate consistency;    (iv) hydroxypropylmethyl cellulose, in an amount from about 0.1-3% by weight;    (v) sodium carbomer, in an amount from about 0.1-1% by weight; and    (vi) de-ionized water, making up the balance,    wherein the formulation possesses the attributes of (a) a semi-solid, essentially clear gel consistency and appearance, and (b) the ability to maintain a presence in the human vagina along with mucous secretions therein in virucidally effective amounts, for at least 24 hours after application thereto.    
     
     
         14 . A kit for vaginal self-use by a female patient in protection against contracting viral infection and against conception as a result of normal heterosexual intercourse, said kit comprising a vaginal applicator comprising a vaginally insertable tubular member having a length of about five inches, and having an aperturable distal end adapted to be positioned adjacent to the patient's cervix when the applicator is fully inserted into the patient's vagina, and at least one unit dose of from about 5-10 mls of a spermicidally and virucidally effective formulation comprising: 
 (i) at least one benzalkonium chloride, in an amount of about 0.10-0.12% by weight;    (ii) octoxynol-9 in an amount of about 0.2% by weight;    (iii) a biologically acceptable emollient, to provide appropriate consistency;    (iv) hydroxypropylmethyl cellulose, in an amount from about 0.1-3% by weight;    (v) sodium carbomer, in an amount from about 0.1-1% by weight; and    (vi) de-ionized water, making up the balance.